162 mg of Aspirin for Prevention of Preeclampsia

Phase 4

• Conditions: Preeclampsia
• Interventions: Drug: Aspirin 162 mg

• Registration Number: NCT05221164
• Lead Sponsor: Methodist Medical Center of Illinois

Brief Summary

This is a study to assess if 162 mg of aspirin will decrease rates of preeclampsia in pregnant patients compared to 81 mg of aspirin.

Detailed Description

After screening to meet inclusion criteria, pregnant patients at the Family Medicine Clinic will be asked to take 162 mg aspirin daily for 6 months, starting at about 12 weeks gestation and continued until the end of pregnancy. They will be monitored every 4 weeks until week 28, then every 2 weeks until week 36, and then weekly from week 36 on. Participants will be screened at these visits for medication compliance (taking, missed doses, side effects, etc). Patients will be subject to lab work as is routinely indicated for preeclampsia.

At the end of the study period, accumulated study data will be compared with historical data from the Family Medicine Clinic on rates of preeclampsia and outcomes in patients taking 81 mg for preeclampsia prevention.

Study Timeline

• Study Start: 2021-07-06
• Study First Submitted: 2021-08-23
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-22
• Last Update Submitted: 2022-01-22
• Study First Posted: 2022-02-02
• Last Update Posted: 2022-02-02
• Primary Completion: 2022-06-09
• Study Completion: 2022-06-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Any pregnant patient at Peoria FMC
• Hx of pre-eclampsia
• Multifetal gestation
• Chronic hypertension
• Type 1 or 2 diabetes
• Autoimmune disease
• Renal disease
• Nulliparity
• Obesity
• Family Hx of pre-eclampsia
• Sociodemographic characteristics
• Age >= 35 years of age
• Personal history factors (LBW, SGA, > 10-year pregnancy interval, adverse pregnancy outcomes

Exclusion Criteria

• At high risk of side effects from ASA therapy
• Hx of hemorrhagic stroke
• Hx of GI bleed, G6PD
• Liver disease
• NSAID or Salicylate allergy)
• Patients confirmed to be not compliant with therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention with 162 mg aspirin	Aspirin 162 mg	Aspirin 162 mg daily for prevention of preeclampsia in pregnant patients at Family Medicine Clinic

Primary Outcome Measures

Name	Time	Method
Number of participants with eclampsia	Anytime during pregnancy and 3 months post partum	new onset of seizures in pregnant woman with preeclampsia
Number of participants with preeclampsia	Through study completion, estimated 18 months	Dangerous pregnancy complication characterized by high blood pressure

Secondary Outcome Measures

Name	Time	Method
Number of participants with placental abruption	Through study completion, estimated 18 months	Separation of placenta from the uterus prior to delivery
Number of participants with post partum hemorrhage	Through study completion, estimated 18 months	blood loss after delivery
Number of participants with aplastic anemia	Through study completion, estimated 18 months	deficiency of all blood cell lines
Number of participants with agranulocytosis	Through study completion, estimated 18 months	deficiency of granulocytes
Number of participants with anaphylaxis	Through study completion, estimated 18 months	serious allergic reaction

Trial Locations

Locations (1)

UnityPoint Clinic Family Medicine; 🇺🇸 Peoria, Illinois, United States